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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06136689
Other study ID # 1WR/DAR15
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date May 1, 2025

Study information

Verified date November 2023
Source Medical University of Warsaw
Contact Kajetan Grodecki, MD, PhD
Phone 0048 660675782
Email kajetan.grodecki@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aims to evaluate composition differences of aortic valves in different stages and phenotypes of aortic stenosis using non-invasive imaging and histology.


Recruitment information / eligibility

Status Recruiting
Enrollment 55
Est. completion date May 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - aortic valve replacement or heart transplant as part of standard care decided by the local Heart Team - pre-surgical computed tomography angiography - informed consent

Study Design


Locations

Country Name City State
Poland Medical University of Silesia Katowice
Poland Poznan University of Medical Sciences Poznan

Sponsors (2)

Lead Sponsor Collaborator
Medical University of Warsaw Polish Cardiac Society

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Grodecki K, Tamarappoo BK, Huczek Z, Jedrzejczyk S, Cadet S, Kwiecinski J, Rymuza B, Parma R, Olasinska-Wisniewska A, Fijalkowska J, Protasiewicz M, Walczak A, Nowak A, Gocol R, Slomka PJ, Reczuch K, Jagielak D, Grygier M, Wojakowski W, Filipiak KJ, Dey D. Non-calcific aortic tissue quantified from computed tomography angiography improves diagnosis and prognostication of patients referred for transcatheter aortic valve implantation. Eur Heart J Cardiovasc Imaging. 2021 May 10;22(6):626-635. doi: 10.1093/ehjci/jeaa304. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Aortic valve tissue composition measured from pre-procedural computed tomography angiography Quantitative analysis of aortic valve composition will be based on pre-surgical planning CTA images using semi-automated software (Autoplaque version 2.5, Cedars-Sinai Medical Center, Los Angeles, CA, USA) for calcified, non-calcified and total tissue volumes. up to 30-days before surgery
Primary Aortic valve tissue composition measured from quantitative histology Different stains will be used to characterize composition of excised aortic valves (hematoxylin and eosin, Movat Pentachrome, Van Gieson's trichrome, Congo Red, anti-CD68 antibody immediately post-surgery
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